Meridia recall says lots about the FDA

The FDA has finally recalled Meridia, Abbott Laboratories’ obesity drug. The final nail-in-the-coffin was a big new study showing that the drug can increase heart attacks and strokes in high-risk patients. But it must be noted that the potential for harm had been obvious from day one. From the very beginning, it was clear the drug raised blood pressure and heart rate. Given this effect, it was always hard to imagine how the drug would have a net benefit to patients. I thought there was a balancing approach to new drug approvals. Way back in 1996, an advisory panel agreed that the blood pressure rise produced by the drug was clinically important. Public Citizen has been petitioning to get the drug off the market since 2002 based on the potential for heart harm.

But back in the good old days (for the drug industry) of the mid-1990s, the FDA was far less stringent about the safety of obesity drugs that would be used by millions. At that juncture, none of the bad drugs had disasters happen. Then came fen-phen and Vioxx. The FDA approved Meridia and kept it on the market for a long time, despite a very modest weight loss benefit and obvious problems with the safety of the drug. Only now that conclusive evidence is in, does the drug get recalled. The question has to be why it took so long to figure out that the drug was too dangerous to be on the market.

The real story here is what appears to be a changing regulatory environment. In the wake of Merck’s Vioxx scandal and the mess relating to GlaxoSmithKline’s Avandia, a drug like Meridia should no longer be allowed to slip through the cracks. Hopefully, the FDA will no longer approve a drug for the masses based on a small symptomatic benefit or mild improvement in a lab value if a medicine isn’t demonstrated to have tangible improvements on patient health down the road. Approving a drug on a hope that it will help folks shouldn’t be enough anymore. Hopefully, things are really changing at the FDA and, if so, consumers will be better protected.